Arterial stapling device

ABSTRACT

A method and device for efficiently and effectively stapling an opening in an anatomical structure such as veins, arteries, organs, and other body members within a living body is disclosed. The opening may be from a deliberately placed incision, as from an invasive surgical procedure, or caused by other damaging events. The device includes a stapling mechanism having a main body with a handle, a trigger for activating the staples, and a central passage through which a balloon catheter may pass. The balloon catheter supports the artery and helps position the stapling mechanism properly on the artery. Alternatively, the device may have a main body that has an inflatable member attached to it and extending from it. The main body provides a passage through which a pressurized media such as saline can be supplied to the inflatable member. In either case, the main body may advantageously include a flashback lumen through which blood or other fluid may flow as an indication of the position of the device within the anatomical structure.

FIELD OF THE INVENTION

The present invention relates to the field of surgical instruments andmore particularly to devices for installing surgical staples in vessels,arteries, organs, and the like.

BACKGROUND OF THE INVENTION

Many surgical procedures require the insertion of catheters and/orsurgical devices into blood vessels and other internal structures. Forexample, in the treatment of vascular disease, it is often necessary toinsert an instrument, i.e., a catheter, into the blood vessel to performthe treatment procedure. Such treatment procedures often involvepiercing a wall of the blood vessel, inserting an introducer sheath intothe blood vessel via the opening, and maneuvering the proceduralcatheter through the introducer sheath to a target location within theblood vessel. Of course in order to complete such a procedure, the sidesof the opening in the wall of the blood vessel must be sealed to preventbleeding while facilitating healing of the wound. At present, thissealing is commonly accomplished by application of direct pressure overthe puncture site by a physician or other trained medical professional.Due to the dangers of thrombosis, the substantial reduction of bloodflow through the blood vessel due to the application of pressure isundesirable and potentially dangerous to the patient. In addition, theprocedure is time consuming; often requiring that pressure be appliedfor forty-five minutes or more to achieve acceptable sealing.

Other sealing techniques include the application of a biogenic sealingmaterial over the opening to seal the wound. However, proper placementof the sealing material is difficult to achieve and, the plug of sealingmaterial left inside the blood vessel may result in serious health risksto the patient.

As a result, devices have been developed which are inserted through thepuncture in order to suture openings created in blood vessels. However,these devices suffer from various drawbacks.

For example, U.S. Pat. No. 5,417,699 to Klein et al. describes a devicewherein two needles coupled to a distal end of an insertion shaft areheld within an outer shaft during insertion into an internal structure.Once inside the internal structure, the inner shaft is drawn proximallyrelative to the outer shaft, so that the needles are simultaneouslydrawn through the walls of the internal structure. The needles are thenremoved from the device, the device is removed and sutures attached tothe needles are tied together to seal the opening. The device of Kleinet al., includes no means for ensuring that the device is properlylocated, is costly to manufacture, and is cumbersome, requiring threehands for operation.

OBJECTS AND SUMMARY OF THE INVENTION

The present invention is directed to an arterial stapling device forsealing a hole in a wall of an anatomical structure within a living bodywhich provides a housing extending from a distal end to a proximalportion, the housing including a catheter receiving lumen extendingtherethrough from a first opening formed in the proximal portion to asecond opening formed in the distal end, wherein when the device is inan operative position with a catheter extending through the catheterreceiving lumen and into the hole, the distal end is located within theliving body adjacent to the hole and the proximal portion remainsoutside the living body. The housing further defines at least a firststaple orifice in the distal end adjacent to the second opening so that,when the device is in the operative position, the first staple orificeextends across a portion of the hole. The device further includes astapling mechanism mounted within the housing adjacent to the firststaple orifice, and an actuating mechanism coupled between the proximalend of the housing and the stapling mechanism for operating the staplingmechanism so that a staple is ejected from the first staple orifice.

The present invention is also directed to a method of sealing a hole inan anatomical structure within a living body including the steps of:

inserting an apparatus for sealing a hole in a wall of an anatomicalstructure into a desired position within the living body wherein theapparatus includes an inflatable structure which, when the device is inthe desired position, extends from a housing of the apparatus into thehole and, wherein the apparatus further includes a stapling mechanismwhich, when the device is in the desired position, is located adjacentto the opening;

inflating the inflatable member to seal the hole;

operating the stapling mechanism to place at least one staple into thewall of the anatomical structure across a portion of the opening whereinthe stapling mechanism operates to form the staple into a sealingconfiguration that draws the sides of the hole together to seal thehole; and

withdrawing the apparatus from the living body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of the arterialstapling device of the present invention.

FIG. 2 is a cross-sectional side view of the device shown in FIG. 1through section A--A.

FIG. 3 is a detail view of the distal end of the device shown in FIG. 2.

FIG. 4 is a top view of the device shown in FIG. 1 through section B--B.

FIG. 5 is an end view of the device shown in FIG. 3 through sectionC--C.

FIG. 6 is a perspective view of the staple pusher according to the firstembodiment of the invention.

FIG. 7 shows an environment of use of the invention.

FIG. 8 shows the environment of use further including a ballooncatheter.

FIG. 9 shows the environment of use with the procedure sheath removed.

FIG. 10 shows the first embodiment of the invention in its environmentof use.

FIG. 11 shows a distal portion of the first embodiment of the inventionin an operative position within a living body.

FIG. 12 shows the first embodiment of the invention with a staple placedin an artery according to the invention.

FIG. 13 shows a puncture site stapled according to the invention.

FIG. 14 shows a side view of a removable hub according to the presentinvention joined to a balloon catheter.

FIG. 15 is a perspective view of a second embodiment of the invention.

FIG. 16 is a top view of the device shown in FIG. 15 through sectionA--A.

FIG. 17 is a side view of the device shown in FIG. 15 through sectionB--B.

FIG. 18 is an end view of the device shown in FIG. 17 through sectionC--C.

FIG. 19 is an end view of the device shown in FIG. 17 through sectionD--D.

FIG. 20 shows an environment of use of the device.

FIG. 21 shows an embodiment of the device with the inflatable bodyportion partially inserted into an artery in a living body.

FIGS. 22-23 shows an embodiment of the device with the inflatable bodyportion fully inserted into the artery so that the device is in positionto staple the artery.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a preferred embodiment of the invention designatedgenerally by the numeral 1. Device 1, which comprises a main body 110,works in conjunction with a balloon catheter (not shown in FIG. 1). Mainbody 110 has, at its proximal end, a handle 111 and trigger 112 and atits distal end, a tubular projection 105. The distal end of tubularprojection 105 may, preferably include optional tabs 114 protrudingdistally therefrom which serve to hold a balloon catheter in an ovalshape. For example, if a balloon catheter having a preformed oval shapeis employed, then tabs 114 may be omitted. Further, tabs 114 may bereleasably attached to the main body 110 so that, when a user feelsthese tabs might inhibit proper closing of the artery puncture site,they may be removed.

As shown in FIG. 2, a trigger 112 is rotatably attached to handle 111for rotation about point 109. A trigger spring 113 biases the trigger112 toward a cocked or ready position in which the trigger 112 is spacedfrom the handle 111 (as shown in FIG. 2). Activating or squeezingtrigger 112 rotates trigger 112 about rotation point 109 toward thehandle 111, thereby advancing staple pushers 121. As staple pushers 121are advanced, they bend the staples 120 into their binding position asis known in the art, and eject the staples from the distal end of mainbody 110. When released, trigger 112 is moved back to the ready positionby trigger spring 113.

A balloon insertion lumen 115 extends through main body 110 from itsproximal to its distal end. As shown in FIG. 10 and discussed in moredetail in the description thereof, a balloon catheter which haspreviously been inserted through a puncture into an artery may bereceived within the balloon insertion lumen 115 so that the device 1 maybe advanced over the balloon catheter until the device 1 reaches adesired position relative to the artery. Main body 110 contains aflashback lumen 117, extending from a blood entry port 118 at the distalend of main body 110 (see FIG. 3) to a blood exit port 119 locatedproximal to blood entry port 118. By observing blood flow (or the lackthereof) through the flashback lumen 117, the user may determine whenthe device 1 is in the desired position relative to the artery.

As shown in FIG. 3, tabs 114 extend distally from the distal end of thetubular projection 105. The balloon insertion lumen 115 is locatedbetween tabs 114. The blood entry port 118 of the flashback lumen 117 islocated adjacent to one of the tabs 114. Through the blood entry port118, blood or fluid from the artery or anatomical structure may enterflashback lumen 117 and traverse therethrough until reaching blood exitport 119. The tab 114 adjacent to the blood entry port 118 may beadvantageously shaped to facilitate passage of blood into the bloodentry port. For example, as shown in FIG. 3, a groove 114.1, which leadsto the blood entry port 118, is formed in one of the tabs 114.

A substantially U-shaped staple 120 is shown at the distal end of mainbody 110. Of course, those skilled in the art will recognize thatstaples of any shape may be employed with this device so long as thestaple pushers 121 are modified accordingly. The u-shape of staple 120represents a staple prior to placement. Staple pusher 121 which bendsand places staple 120 due to the functionally stylized shape of staplepusher 121, includes lateral grooves 126, longitudinal grooves 127, andramps 128 at its distal end adjacent staples 120.

Staple pushers 121 are connected to trigger 112 at the proximal end ofdevice 1 and extend longitudinally to the distal end of device 1. Asshown in FIG. 4, balloon insertion lumen 115 extends from the proximalto the distal end of main body 110. In the embodiment shown in FIG. 4,two staple pushers 121 are located substantially symmetrically on eachside of balloon insertion lumen 115. Activation of trigger 112 pushesboth staple pushers 121 simultaneously, thus, simultaneously placing twostaples 120 into the artery. Those skilled in the art will recognizethat, for use with different size arteries, devices of various sizes maybe employed having any number of staple pushers 121--one staple pusher121 for very thin arteries with the number of staple pushers increasingas the diameter of the artery increases. Large arteries mayadvantageously be stapled by a device having 3 or more staple pushers121 activated simultaneously to place three staples 120. A furtherembodiment of the invention may include two independent triggers 112each attached to an independent staple pusher 121 or pair of staplepushers, to thereby allow a user to place one or more staplesindependently of other staples. This would permit manipulation of thedevice between placement of the staples 120.

As shown in FIG. 5, tabs 114 may be located above and below ballooninsertion lumen 115, with the tabs 114 illustrated extending distallyout of the page toward the viewer, while the balloon insertion lumen 115extends proximally into the page through main body 110. Flashback lumen117 is adjacent to one of the tabs 114 and the staples 120 are locatedsubstantially symmetrically about a center line 125 of the tubularprojection 105. A staple bending stop 122 adjacent to the staple lumen123 is centrally located around the balloon insertion lumen 115. When astaple 120 is pushed (from behind) by staple pusher 121, staple 120bends (forward) around staple bending stop 122. Continued pushing bringsramps 128 of staple pusher 121 into contact with staple 120 which causesthe bent staple 120 to be pushed laterally outward from center line 125so that the staple 120 is ejected through staple exit lumen 124.

As shown in FIG. 6, the proximal end of staple pusher 121 is connectedto trigger 112. The distal end of staple pusher 121 has a stylized shapethat allows staple pusher 121 to carry out its stapling function.Lateral grooves 126 initially contact staple 120 when trigger 112 isheld in the cocked or ready position. When trigger 112 is activated,lateral grooves 126 apply pressure on staple 120 and begin to bendstaple 120 about staple bending stop 122. Continued pushing by staplepusher 121 brings longitudinal grooves 127 into contact with staple 120to complete the bending process. Staple pusher 121 has ramps 128 whichcontact a bent staple 120 at the end of the stroke of trigger 112. Ramps128, by virtue of their wedge-like shape, displace staple 120 aroundstaple bending stop 122 and thereby cause staple 120 to pass throughstaple exit lumen 124 and ultimately be released from device 1.

Having described the mechanical flnctionality of arterial staplingdevice 1, a functional use within a living patient will be discussed.FIG. 7 shows an environment for the use of device 1. It is common formedical procedures to employ a procedure sheath 510, also called anintroducer. Procedure sheath 510 penetrates the skin line 501 at skinopening 503 and passes through tissue 504 to enter artery 500 atpuncture site 502. Through a longitudinal bore in procedure sheath 510,medical instrumentation may be inserted into artery 500. For example, asshown in FIG. 8, a balloon catheter 520 is inserted through proceduresheath 510 to thereby gain a position within artery 500 and tissue 504.

As shown in FIG. 9, procedure sheath 510 may be removed from theprocedure site while leaving balloon catheter 520 in place. Device 1 ofthe invention works in conjunction with a balloon catheter 520 which hasbeen placed in artery 500. An appropriate inflation pressure for ballooncatheter 520 for use in veins, arteries, and the like will depend uponthe particular application and may range from approximately 1 to 50 PSI.

FIG. 10 shows device 1 positioned by sliding the device 1 over ballooncatheter 520 via balloon insertion lumen 115. With device 1 insertedover the balloon catheter, removable hub 150 can be applied to theexternal end of balloon catheter 520. Removable hub 150 includes aballoon inflation port 151, to which an external supply of saline orother suitable media (not shown) is attached in order to pressurize andinflate balloon catheter 520. One advantageous feature of the inventionis that, when inflated, the balloon catheter 520 substantially seals thepuncture site, reducing bleeding before the actual stapling processoccurs.

Device 1 must be inserted under the skin line 501 and through tissue 504so that the distal end of the tubular projection 105 is flush with thewall of artery 500. If optional tabs 114, which extend distally from thedistal end of the tubular projection 105, are included, they may extendinto the artery 500. When device 1 is properly inserted, blood entryport 118 receives blood from artery 500. The blood traverses throughflashback lumen 117 to blood exit port 119 and thereby indicates to theuser that device 1 is properly positioned for stapling.

FIG. 11 shows the distal end of device 1 positioned appropriately inartery 500. Tabs 114 are in artery 500 so that blood flows into bloodentry port 118 through flashback lumen 117, to indicate that the deviceis properly positioned in artery 500. Staple 120 is shown in its bentposition. When staple 120 is bent by staple pusher 121, it penetratesartery 500 and, upon continued bending, it also penetrates and deflatesballoon catheter 520. The deflated balloon catheter 520 may then bewithdrawn through the now sealed puncture, into the balloon insertionlumen 115 while device 1 remains in place adjacent artery 500. To assistin this puncture and removal, balloon catheter 520 may preferably bemade of a material that easily tears axially. Thus, balloon catheter 520tears around staple 120 and is therefore easily removed from theprocedure site.

An alternative procedure would allow balloon catheter 520 to be removedprior to being punctured by staple 120. For example, when staple 120penetrates artery 500, but before it penetrates balloon catheter 520,balloon catheter 520 may be deflated and removed from the puncture sitethrough balloon insertion lumen 115. Staple 120 may then be inserted therest of the way into artery 500 to complete the procedure.

FIG. 12 shows device 1 after staple 120 has been fully ejected fromdevice 1 through activation of the staple pusher 121 as discussed above.Tabs 114 are not depicted in this view in order to show an unobstructedview of the stapled puncture site. Staple 120 clamps the puncture siteclosed with no other foreign matter left within artery 500. When thestaple 120 is released from staple exit lumen 124 (FIG. 5), device 1 maybe removed from the puncture site 502.

FIG. 13 shows the puncture site 502 after device 1 has been removed. Twostaples 120 are arranged across the puncture site 502, thereby holdingthe puncture in artery 500 closed. Of special importance is the abilityof a user to properly orient the device relative to artery 500 in orderto properly place staples 120. For example, as shown, staples 120 arealigned longitudinally with respect to the axis of artery 500.Alternatively, a user may place staples 120 at other orientationsrelative to artery 500 by positioning device 1 as desired beforeactivating trigger 112. The user must be cognizant of both the anatomyof the living body (i.e. the position and orientation of the artery 500within the living body) and the position and orientation of the staplingdevice in order to properly orient the staples 120 with respect to thepuncture site 502.

FIG. 14 shows a side view of balloon catheter 520 joined with removablehub 150. Hub 150 is initially coupled to the balloon catheter 520 afterthe balloon catheter 520 has been inserted through the balloon insertionlumen 115 of device 1. In FIG. 14, the balloon catheter 520 and hub 150are shown, for example, after the balloon catheter 520 has been removedfrom the puncture. If the balloon catheter 520 is to be removed from thepuncture site without being deflated by the staples 120 (as discussedwith reference to FIG. 11), the wide portion of balloon catheter 520will have to decrease in size to fit into balloon insertion lumen 115.This can be accomplished by accumulator 153 of removable hub 150. Asballoon catheter 520 is drawn into balloon insertion lumen 115, thefluid in balloon catheter 520 flows out of balloon catheter 520 intoaccumulator 153 which is pressure expandable, i.e., when a volume offluid flows into accumulator 153, the volume of accumulator 153 isexpanded to maintain a constant pressure. Thus, balloon catheter 520 maybe removed through balloon insertion lumen 115 while maintaining aconstant system pressure throughout both balloon catheter 520 andremovable hub 150.

As shown in FIG. 14, removable hub 150 may be removably joined toballoon catheter 520 by a compression seal 154. Once joined, fluid maybe added to the removable hub 150 (and hence to balloon catheter 520)through its balloon inflation port 151 which includes a check valvediaphragm 152.

A preferred arrangement for the use of balloon catheters generallyincludes a support wire 521 which is connected to the proximal end ofballoon catheter 520 at attachment point 522. At the distal end ofballoon catheter 520, the support wire 521 tapers to allow flexibilityand is inserted into a spring coil or plastic sleeve 523 which is formedinto a "J" shaped tip 524 which allows safe and convenient insertioninto arteries and such as is known in the art.

A second embodiment of the invention will be discussed in reference toFIG. 15 through 23. FIG. 15 shows a perspective view of the secondembodiment of the invention, wherein the device is generally designatedby the numeral 2. Device 2 has a main body 210 having, at is proximalend, a handle 211 and a trigger 212. Main body 210 houses staples 220.When device 2 is appropriately positioned for stapling, activation oftrigger 212 bends the staples into a desired configuration and ejectsthe staples 220 from the staple ports 221, in any suitable manner, suchas was discussed with reference to the first embodiment of thisinvention.

An elongated inflatable body 230 extends distally from the distal end ofmain body 210. Inflatable body 230 is formed of a pliable membrane whichincludes internal passages. One such passage is guide wire lumen 231, towhich access is provided by guide wire inlet 232 which is located at thedistal end of the inflatable body 230.

Inflatable body 230 is pressurized by a supply of saline solution orother suitable media (not shown). The solution may be introduced througha supply tube 241 coupled to the supply by port 242 which has a valve243 to control the flow of the pressurized media. The supply tube 241may be attached to device 2 by any suitable manner at supply orifice245.

FIG. 16 and 17 show device 2 containing internal passages 240, 231, 250of device 2, which are used for inflating inflatable body 230, providingpassage of the guide wire, and other purposes, such as allowing passageof blood to indicate the position of device 2 within artery 500 (shownin FIG. 20 and 21). Main body 210 contains pressure supply passage 240to which supply tube 241 connects at the proximal end of main body 210.Pressure supply passage 240 has a supply outlet 244 at the interfacebetween main body 210 and inflatable body 230.

Main body 210 also contains a flashback lumen 250 which has a blood exitport 251 on the exterior of main body 210 and a blood entry port 252 onthe proximal end of the inflatable body 230. When blood entry port 252is located within artery 500, blood will enter the blood entry port 252,pass through flashback lumen 250, and exit the blood exit port 251. Whenblood exits the blood exit port 251, the attending physician or otheruser of device 2 will know that the blood entry port 252 is locatedwithin artery 500. Knowing the relative position of device 2 withinartery 500, the user can determine when to activate trigger 212 toinsert staples 220. A portion of flashback lumen 250 is located in mainbody 210 and a portion is located in inflatable body 230. The portion offlashback lumen 250 in inflatable body 230 is delimited by an adhesivebarrier 253 which occludes flashback lumen 250.

As shown in FIG. 17, supply tubing 241 may be attached to the pressuresupply passage 240 at the proximal end of main body 210. Pressure supplypassage 240 is connected with inflatable body 230 at the interface ofmain body 210 and is connected to inflatable body 230 at supply outlet244.

Flashback lumen 250 extends from the proximal end of main body 210through a portion of inflatable body 230 and to a blood inlet port 252.An adhesive barrier 253 located on the distal side of the port 252,seals the flashback lumen 250. At the distal end of inflatable body 230,guide wire inlet 232 provides access for a guide wire to enter guidewire lumen 231. Guide wire lumen 231 is provided with guide wire exitport 233 proximal to guide wire inlet 232. An adhesive barrier 234separates guide wire lumen 231 from the other internal passages ofinflatable body 230.

As shown in FIG. 18, inflatable body 230 contains guide wire lumen 231having a guide wire exit port 233, separated from the proximal end ofinflatable body 230 by a predetermined distance. According to a stillfurther embodiment of the invention, guide wire exit port 233 may belocated on main body 210, wherein the guide wire enters inflatable body230 via a guide wire inlet 232, located at the proximal end of theinflatable body 230, and remains within the inflatable body 230 for itsentire length.

As shown in FIG. 19, the distal end of main body 210 holds staples 220within the staple openings 221. It is further shown that inflatable body230 contains flashback lumen 250 and that a blood entry port 252 islocated on the side of inflatable body 230.

FIG. 20 shows an environment of use for the arterial stapling device 2.Artery 500 is located within a living body below the surface of the skin501. A guide wire 540, which may be used for numerous medicalprocedures, is shown penetrating the skin 501 at skin opening 503,passing through tissue 504, and entering artery 500 at puncture site502.

FIG. 21 shows the arterial stapling device 2 partially inserted intoartery 500. In the position shown, guide wire 540 is inserted into guidewire lumen 231 of inflatable body 230 with the inflatable body 230penetrating artery opening 502 by being moved along the path as guidedby guide wire 540.

FIG. 22 shows device 2 in the position at which staple 220 may beinserted into artery 500. Preferably before activating trigger 212,guide wire 540 should be withdrawn from the artery and thus from guidewire lumen 231 of device 2. As shown in FIG. 22, guide wire 540 has beenremoved entirely from the environment, having been withdrawn from guidewire lumen 231, from artery opening 502, and from the skin opening 503.

The inflatable body 230 is inserted into artery 500 such that bloodentry port 252 is inside artery 500. Such a position allows blood toenter flashback lumen 250 through blood entry port 252, and exit throughblood exit port 251. The flow of blood through flashback lumen 250provides the user of device 2 with information about the position ofdevice 2 relative to artery 500.

An advantageous feature of the invention is that artery 500 is providedwith support from inflatable body 230, which thereby facilitatesinsertion of staples 220 into the wall of artery 500. By selection of anappropriately sized and shaped inflatable body 230, artery 500 may besufficiently filled by the inflatable body 230 to thereby seal off bloodflow during the stapling procedure. It may be desirable to have aninflatable body 230 which has a different, e.g. smaller, diameter whereit will reside in the artery, than it does where it will support theartery near the puncture site 502.

FIG. 23 shows device 2 after trigger 212 has been activated and staple220 is in place in artery 500. Staple 220 penetrates the wall of artery500 as well as inflatable body 230, thereby deflating it.

Inflatable body 230 is made of such a material that when it is puncturedby staple 220, the material rips longitudinally in order to be pulledthrough staple 220 for removal from artery 500. Thus, no foreignmaterial is left in artery 500 after the deflated inflatable body 230has been pulled through staple 220.

Those skilled in the art will understand that staple size and dimensionsof the device may be determined by the application to which it isapplied. For example, in relatively small arteries, relatively smallcomponents must be used, whereas, for larger arteries, a device havingrelatively larger components may be appropriate. The balloon catheterover which a first embodiment of the device is applied, or theinflatable body portion of a second embodiment of the device, can berelatively short or long depending on the specific procedure.

Because the present invention is capable of various modifications andalternate constructions, the specification is not intended to limit theinvention to the specific embodiments disclosed herein. Rather, it isintended to be limited only by the claims appended hereto.

What is claimed is:
 1. A device for sealing a wall opening in ananatomical structure of a living body comprising:a body having aproximal portion and a distal end, wherein an inflation lumen extendswithin the body from an inflation lumen outlet formed on the distal endof the body, to an inflation lumen inlet formed on the proximal portionof the body; a stapling mechanism disposed within the distal end of thebody; an actuating mechanism coupled between the proximal portion of thebody and the stapling mechanism; and an inflatable member coupled to thedistal end of the body and extending distally therefrom, wherein, whenthe inflatable member is in position on the distal end of the body, aninternal space of the inflatable member is in fluid communication withthe inflation lumen outlet; wherein, when the device is in an operativeposition, the inflatable member extends through the wall opening, thedistal end of the body is located within the living body adjacent to thewall opening, the proximal portion of the body remains outside theliving body, and the stapling mechanism is located such that, uponactivation of the actuating mechanism, a staple is placed into theanatomical structure so that the staple extends across a portion of thewall opening to thereby seal the wall opening.
 2. The device accordingto claim 1 further comprising:a guide wire lumen extending through theinflatable member from a guide wire inlet formed on the distal end ofthe inflatable member to a guide wire exit formed on the proximalportion of the inflatable member.
 3. The device according to claim 1,further comprising:a first flashback lumen section extending within thebody between a first connection port formed on the distal end of thebody and a fluid exit port formed on the proximal portion of the body;and a second flashback lumen section extending within the inflatablemember from a second connection port in fluid communication with thefirst connection port to a fluid entry port formed on the inflatablemember distally of the second connection port.
 4. A method for sealing awall opening in a wall of an anatomical structure within a living bodycomprising the steps of:inserting an apparatus for sealing a wallopening in a wall of an anatomical structure into a desired positionwithin the living body wherein the apparatus includes an inflatablestructure which, when the device is in the desired position, extendsfrom a housing of the apparatus into the wall opening and, wherein theapparatus further includes a stapling mechanism which, when the deviceis in the desired position, is located adjacent to the opening;inflating the inflatable member to seal the wall opening; partiallyactuating the stapling mechanism, sufficient only to insert a stapleinto the wall of the anatomical structure, but not sufficient to placethe staple into the balloon catheter located within the anatomicalstructure, wherein the staple is placed into the wall across a portionof the opening; withdrawing the balloon catheter from the proximal endof the stapling device by decreasing the volume of the balloon catheterdistal to the stapling device, by purging pressurizing medium from theballoon catheter, so that the balloon catheter will fit through theinsertion lumen of the stapling device; further actuating the staplingmechanism to form the staple into a sealing configuration that draws thesides of the wall opening together to seal the wall opening; andwithdrawing the apparatus from the living body.